++DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“module” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a module” which renders the claim indefinite as the specification does not disclose the structure of the term “module”, and there is no corresponding structure described in the claims or specification for the 35 U.S.C. 112(f) or pre-AIA U.S.C 112, sixth paragraph limitation, see paragraph 0062. For purposes of examination, examiner interprets “module” as a processor & associated software capable of analyzing signals and generating instructions for other devices.
Claims 2-3 are rejected for the same reason.
Claims 4-10 are rejected as they depend on and comprise a rejected claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 7, 9-10 are rejected under 35 U.S.C. 102(a)(1), (a)(2) as being anticipated by Jacobs et al (United States Patent Application Publication 20010033805)
As to claim 1, Jacobs teaches a system (paragraph 0003 “This invention relates to an apparatus and method for monitoring cleaning processes for medical devices.”), comprising:
a basin (Figure 14, paragraph 0182 “washing chamber 20”) configured to receive a fluid (paragraph 0177 “washing liquid in chamber 20”) and a medical device to be treated during a treatment process (Figure 14, paragraph 0168 “a washing chamber 20 for washing medical devices and instruments such as a medical device 22 with a lumen and surgical instrument 24.”);
a detector (Figure 14, paragraph 0184 “detector 112” next to enclosure 102), coupled with the basin (paragraph 0182 “Enclosure 102 is in controllable fluid communication with chamber 20.”), configured to measure an electromagnetic property of the fluid during the treatment process (paragraph 0184 “light can travel through the body of the washing liquid in the enclosure and reach to detector 112”); and
a module (Figure 9, paragraph 0169 “electrical circuitry 80”), coupled with the detector, configured to determine, based on the electromagnetic property of the fluid, an analyte level in the fluid (paragraph 0182 introduces “A chemical suitable for reacting with the soil in the washing liquid to generate a detectable signal” and paragraph 0183 “intensity of the signal generated by the reaction between the chemical and the washing liquid will reflect only the content of soil in the washing liquid”).
As to claim 2, Jacobs teaches everything claimed, as applied above in claim 1, in addition the module is further configured to generate an instruction to adjust a treatment process parameter or an analyte content value (paragraph 0178 “a determination is made if sufficient rinsing and/or cleaning has taken place and an additional rinse or wash and rinse cycle are necessary”).
As to claim 3, Jacobs teaches everything claimed, as applied above in claim 1, in addition the module is further configured to adjust, based on the electromagnetic property of the fluid or the analyte level in the fluid, a treatment process parameter (paragraph 0167 “If the soil determined in the aforementioned method in step (b) is not substantially equal to the soil determined in step (a), either the cleaning step or rinsing step or all steps of the cleaning process are repeated until the soil determined in step (b) is substantially equal to the soil determined in step (a).”).
As to claim 4, Jacobs teaches everything claimed, as applied above in claim 3, in addition the treatment process parameter comprises at least one of a treatment temperature, a treatment time, a treatment pressure, a treatment agent concentration, a treatment agent type, and a cycle start/stop parameter (paragraph 0167 teaches ‘if (b) is equal to (a) then stop the cleaning process’).
As to claim 5, Jacobs teaches everything claimed, as applied above in claim 1, in addition the detector comprises an electromagnetic radiation source configured to be in electromagnetic communication with the fluid and configured to emit electromagnetic radiation into the fluid (Figure 14, paragraph 0184 “at least a portion of the wall of enclosure 102 should be transparent to the light from the light source 114 so that the light can travel through the body of the washing liquid in the enclosure and reach to detector 112”).
As to claim 7, Jacobs teaches everything claimed, as applied above in claim 1, in addition the detector further comprises an electromagnetic radiation sensor configured to be in electromagnetic communication with the fluid and configured to detect electromagnetic radiation in the fluid (Figure 14, paragraph 0184 “at least a portion of the wall of enclosure 102 should be transparent to the light from the light source 114 so that the light can travel through the body of the washing liquid in the enclosure and reach to detector 112”).
As to claim 9, Jacobs teaches everything claimed, as applied above in claim 1, in addition the fluid comprises at least one of water, a treatment agent, and a reagent (paragraph 0176 “fresh clean water, or other washing or rinsing liquid”, paragraph 0182 “A chemical suitable for reacting with the soil in the washing liquid to generate a detectable signal, such as color, is stored in the chemical source.”).
As to claim 10, Jacobs teaches everything claimed, as applied above in claim 1, in addition the treatment process comprises at least one of a cleaning process, a disinfecting process, and a sterilization process (paragraph 0003 “This invention relates to an apparatus and method for monitoring cleaning processes for medical devices. More particularly, this invention relates to an apparatus and method capable of determining when the device is sufficiently cleaned so that the device can be sterilized.”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 6, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobs.
As to claim 6, Jacobs teaches everything claimed, as applied above in claim 5, with the exception of the electromagnetic radiation source comprises at least one of an incandescent bulb, a fluorescent bulb, a lamp, a light emitting diode, a laser diode, and a monochromator. However, Jacobs teaches the use of a laser (paragraph 0148 “Laser systems utilizing optical fibers for transmission from the laser and to the detector from the sample can also be employed for evaluation of solution clarity or many other properties.”) and it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to use any of the claimed light sources, since the selection of any of these known equivalents would be an obvious matter of engineering choice within the level of one of ordinary skill in the art. See MPEP 2144.06(II).
As to claim 18, Jacobs teaches everything claimed, as applied above in claim 11, in addition determining the analyte level further comprises: comparing emitted electromagnetic radiation and detected electromagnetic radiation to determine the analyte level (paragraph 0148 “the clarity of a solution can be determined through a measurement of the color, reflectance, absorbance, transmittance etc. of the liquid” and it is obvious that an absorbance measurement is made by knowing the initial and final light properties and comparing them); or calculating the analyte level from the detected electromagnetic radiation alone.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Jacobs, further in view of Molnar (United States Patent 5291626).
As to claim 8, Jacobs teaches everything claimed, as applied above in claim 7, with the exception of the electromagnetic radiation sensor comprises at least one of a photomultiplier, a photodiode, a silicon detector, and a charge-coupled device. However, it is known in the art as taught by Molnar. Molnar teaches analyzing light that has passed through a liquid (Figure 1, column 2:36-38 “a turbidity measuring device capable of self-calibration and adjusting for signal attenuation”) where the electromagnetic radiation sensor comprises at least one of a photomultiplier, a photodiode, a silicon detector, and a charge-coupled device (Figure 5, column 11:5-8 “sensors 120 and 130 are each respectively illustrated as comprising a photodetector, such as photodiodes 122 and 132, respectively”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have the electromagnetic radiation sensor comprise at least one of a photomultiplier, a photodiode, a silicon detector, and a charge-coupled device, in order to take advantage of their low cost and reliability.
Claims 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobs, further in view of Centanni (United States Patent 7431886).
As to claim 11, Jacobs teaches a method, comprising:
measuring, by a detector, an electromagnetic property of a fluid (Figure 14, paragraph 0184 “detector 112”, paragraph 0184 “light can travel through the body of the washing liquid in the enclosure and reach to detector 112”) used during a treatment process to treat a medical device in a treatment apparatus (Figure 14, paragraph 0168 “a washing chamber 20 for washing medical devices and instruments such as a medical device 22 with a lumen and surgical instrument 24.”);
determining, based on the electromagnetic property of the fluid, an analyte level in the fluid during the treatment process (paragraph 0182 introduces “A chemical suitable for reacting with the soil in the washing liquid to generate a detectable signal” and paragraph 0183 “intensity of the signal generated by the reaction between the chemical and the washing liquid will reflect only the content of soil in the washing liquid”).
Jacobs does not teach generating a message based on the analyte level to indicate a status of the treatment process. However, it is known in the art as taught by Centanni. Centanni teaches monitoring a washing process (Abstract “A method to detect, control, monitor, maintain and confirm concentration levels of a decontaminant throughout a decontamination cycle is also provided.”) including generating a message based on the analyte level to indicate a status of the treatment process (column 3:27-30 “Processing system 34 and/or control unit 36 may be electrically or electromagnetically connected with an output device (not shown), such as a speaker, a monitor, a display device and a printer, for providing audible and/or visual information.”, see also Figure 2, step 54 and column 10:14-16 “sending an electronic signal to a remote computer (not shown), thus alerting a remote operator or controller”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to be generating a message based on the analyte level to indicate a status of the treatment process, in order to allow a user to respond to events during the process.
As to claim 12, the method would flow from claim 9.
As to claim 13, the method would flow from claim 2, where the ‘stop the wash and rinse cycle’ would change all of the claimed parameters.
As to claim 14, the method would flow from claim 3.
As to claim 15, Jacobs teaches everything claimed, as applied above in claim 11, in addition the electromagnetic property comprises one of absorbance, transmittance, scattering, photoluminescence, or reflectance (paragraph 0138 “the clarity of a solution can be determined through a measurement of the color, reflectance, absorbance, transmittance etc. of the liquid.”).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobs, further in view of Perrett et al (United States Patent Application Publication 20130224869).
As to claim 16, Jacobs teaches everything claimed, as applied above in claim 11, in addition measuring the electromagnetic property of the fluid further comprises: emitting electromagnetic radiation having a wavelength in a range of 330 nm to 390 nm into the fluid (paragraph 0150 teaches “ultraviolet (UV) absorption spectrophotometry” which indicates the use of UV light which includes the claimed wavelengths); and detecting photoluminescence of a fluorescent product at a wavelength (paragraph 0112 teaches “fluorometry” which indicates the detection of fluorescent light).
Jacobs does not explicitly teach the claimed excitation or detection wavelengths. However, it is known in the art as taught by Perrett. Perrett teaches analyzing used medical equipment (Abstract “An imaging system (10) and associated method for detection of protein contamination on a surgical instrument”) where measuring the electromagnetic property further comprises: emitting electromagnetic radiation having a wavelength in a range of 330 nm to 390 nm (paragraph 0016 “The light of the excitation type may typically be in the range of 270 nm to 370 nm.”); and detecting photoluminescence of a fluorescent product (paragraph 0006 “Fluorophors in the stain are capable of emitting light of an emitted type when and only when both excited by light of an excitation type and in contact with a protein.”) at a wavelength in a range of 436 nm to 475 nm (paragraph 0015 “The system may further comprise a filter between the specimen and the first image capture device, the filter adapted to transmit light of said emitted type and to prevent transmission of light of said excitation type. The filter is preferably adapted to transmit only light having a wavelength in the range of 430 nm to 450 nm.”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have the measuring of the electromagnetic property further comprise: emitting electromagnetic radiation having a wavelength in a range of 330 nm to 390 nm; and detecting photoluminescence of a fluorescent product at a wavelength in a range of 436 nm to 475 nm, in order to more easily and accurately detect analytes of interest.
As to claim 17, Jacobs teaches everything claimed, as applied above in claim 11, with the exception of wherein measuring the electromagnetic property of the fluid further comprises: detecting photoluminescence from a reaction product formed when a reagent reacts with protein in the fluid. However, it is known in the art as taught by Perrett. Perrett teaches measuring the electromagnetic property of the fluid further comprises: detecting photoluminescence from a reaction product formed when a reagent reacts with protein in the fluid (paragraph 0007 “According to a first aspect of the invention, there is provided an imaging system for detection of protein contamination on a specimen that has been treated with a fluorescing stain, wherein fluorophors in the stain are capable of emitting light of an emitted type when both excited by light of an excitation type and in contact with a protein” and paragraph 0010 “a first image capture device adapted to capture a second image, of patterns of fluorescence emitted by the fluorophors in the stain on the specimen, corresponding to protein contamination”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to be measuring the electromagnetic property of the fluid further comprises: detecting photoluminescence from a reaction product formed when a reagent reacts with protein in the fluid, in order to more easily and accurately detect a protein of interest.
Conclusion
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/J.C.U/Examiner, Art Unit 2877
/MICHELLE M IACOLETTI/Supervisory Patent Examiner, Art Unit 2877
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